CROSS-REFERENCEThis application is a continuation-in-part of co-pending application Ser. No. 13/717,599 filed Dec. 17, 2012, which is a continuation-in-part of application Ser. No. 13/570,374, filed Aug. 9, 2012, which applications are hereby incorporated herein, in their entireties, by reference thereto, and to which applications we claim priority under 35 USC §120. This application also references application Ser. No. 13/717,565 filed Dec. 17, 2012, which application is hereby incorporated herein, it its entirety, by reference thereto.
FIELD OF THE INVENTIONThe present invention relates to the field of orthopedic surgery, in particular to devices, systems and assemblies for stabilizing and/or fixing bones and/or joints in a patient. More particularly, the present invention relates to instruments, assemblies and methods for correcting spinal alignment.
BACKGROUND OF THE INVENTIONThe fixation and/or stabilization of bones and/or bone fragments is/are commonly required by orthopedic surgeons to treat injuries such as fractures or disease. To accomplish this, the bones/bone fragments can be joined by a rod, plate or the like, which is fixed to the bones/bone fragments via fasteners such as screws, pins or the like. The connection by the rod(s), plate(s) or the like maintains the bones/bone fragments in a desired orientation and/or at desired spacings, positions, etc.
In spinal surgery, it is often necessary to secure various implants to the vertebrae and interconnect the vertebrae by attaching one or more rods or plates to the implants. Due to the complex curvature of the spine, as well as irregularities of the same that often need to be treated, it is often difficult to align a rod or plate with all of the implants/fasteners fixed to the various vertebrae to be connected via the rod or plate. In some surgeries, it is necessary to span multiple vertebrae of the spine with rods that provide stabilizing forces to the vertebrae to help maintain the desired orientations of the vertebrae to maintain a desired curvature in the spine. In these instances, repositioning of multiple vertebrae is often required, often by repositioning relative to multiple planes, in order to achieve the desired alignment of the vertebrae and correct the curvature of the spine/deformity being treated.
There is a need for instruments, assemblies and procedures to facilitate such complex realignment procedures. There is a need for instrument, assemblies and methods that not only can perform these complex procedures, but which also facilitate the ability to more readily attach the instruments when the vertebrae are out of alignment and where it would be otherwise difficult or impossible, using conventional instrumentation to interconnect instrumentation being used because of extreme malalignment of the vertebrae being treated.
SUMMARY OF THE INVENTIONAccording to one aspect of the present invention, a system for correcting alignment of one or more vertebrae of a spine is provided, including: the first elongate derotator member comprising a first elongate element having a first proximal end portion and a first distal end portion, the first distal end portion being releasably engageable with a first implant implanted in one of the vertebrae; a second elongate derotator member comprising a second elongate element having a second proximal end portion and a second distal end portion, said second distal end portion being releasably engageable with a second implant implanted in the one of the vertebrae; and a transverse member engageable with the first and second proximal end portions of the first and second elongate elements; wherein a first channel extends axially through the first elongate element and a second channel extends axially through the second elongate element such that a proximal end portion of the first implant can be accessed from a proximal end portion of the first elongate element by inserting a tool through the first channel when the first elongate derotator member is engaged with the first implant and a proximal end portion of the second implant can be accessed from a proximal end portion of the second elongate element by inserting the tool or another tool through the second channel when the second elongate derotator member is engaged with the second implant.
In at least one embodiment, the proximal end portion of the first implant can be accessed from the proximal end portion of the first elongate element by inserting a tool through the first channel when the transverse member is engaged with the first proximal end portion of the first elongate element and wherein the proximal end portion of the second implant can be accessed from the proximal end portion of the second elongate element by inserting the tool or another tool through the second channel when the transverse member is engaged with the proximal end portion of the second elongate element.
In at least one embodiment, the first elongate derotator member further comprises a third elongate element slidable over the first elongate element, wherein the third elongate element is distally slidable relative to the first elongate element to lock engagement of the first distal end portion with the first implant; and wherein the second elongate derotator member further comprises a fourth elongate element slidable over the second elongate element, wherein the fourth elongate element is distally slidable relative to the second elongate element to lock engagement of the second distal end portion with the second implant.
In at least one embodiment, the system further includes the first and second implants.
In at least one embodiment, the system further includes: a first linking member configured to engage the transverse member with the first proximal end portion of the first elongate element; and a second linking member configured to engage the transverse member with the second proximal end portion of the second elongate element; wherein the first linking member is releasably engageable with the first proximal end portion of the first elongate element and the second linking member is releasably engageable with the second proximal end portion of the second elongate element.
In at least one embodiment, the first linking member comprises a distal end portion having a first longitudinal axis aligned with a longitudinal axis of the first elongate member when the first linking member is engaged with the first elongate member, and a proximal end portion configured to engage with the transverse member, the proximal end portion of the first linking member having a second longitudinal axis offset from the first longitudinal axis; and the second linking member comprises a distal end portion having a third longitudinal axis aligned with a longitudinal axis of the second elongate member when the second linking member is engaged with the second elongate member, and a proximal end portion configured to engage with the transverse member, the proximal end portion of the second linking member having a fourth longitudinal axis offset from the third longitudinal axis.
In at least one embodiment, the system further includes a first ball joint interconnecting the proximal end portion of the first linking member with the distal end portion of the first linking member; and a second ball joint interconnecting the proximal end portion of the second linking member with the distal end portion of the second linking member.
In at least one embodiment, the system further includes: a third elongate derotator member comprising a third elongate element having a third proximal end portion and a third distal end portion, the third distal end portion being releasably engageable with a third implant implanted in a second one of the vertebrae; a fourth elongate derotator member comprising a fourth elongate element having a fourth proximal end portion and a fourth distal end portion, the fourth distal end portion being releasably engageable with a fourth implant implanted in the second one of the vertebrae; and a second transverse member engageable with the third and fourth proximal end portions of the third and fourth elongate elements; wherein a third channel extends axially through the third elongate element and a fourth channel extends axially through the fourth elongate element such that a proximal end portion of the third implant can be accessed from a proximal end portion of the third elongate element by inserting the tool or another tool through the third channel when the third elongate derotator member is engaged with the third implant and a proximal end portion of the fourth implant can be accessed from a proximal end portion of the fourth elongate element by inserting the tool or another tool through the fourth channel when the fourth elongate derotator member is engaged with the fourth implant.
In at least one embodiment, the system further includes an interlevel linking assembly extending between and engaged with the first elongate derotator member and the third elongate derotator member.
In another aspect of the present invention, a system for correcting alignment of one or more vertebrae of a spine includes: a first elongate derotator member comprising a first elongate element having a first central longitudinal axis, a first proximal end portion and a first distal end portion, the first distal end portion being releasably engageable with a first implant implanted in one of the vertebrae; a second elongate derotator member comprising a second elongate element having a second central longitudinal axis, a second proximal end portion and a second distal end portion, the second distal end portion being releasably engageable with a second implant implanted in the one of the vertebrae; and a transverse member engageable with the first and second proximal end portions of the first and second elongate elements; wherein the first central longitudinal axis is substantially aligned with a longitudinal axis of a head of the first implant when the first elongate derotator member is engaged with the first implant, and wherein the second central longitudinal axis is substantially aligned with a longitudinal axis of a head of the second implant when the second elongate derotator member is engaged with the second implant.
In at least one embodiment, the first elongate derotator member further comprises a third elongate element slidable over the first elongate element, wherein the third elongate element is distally slidable relative to the first elongate element to lock engagement of the first distal end portion with the first implant; and the second elongate derotator member further comprises a fourth elongate element slidable over the second elongate element, wherein the fourth elongate element is distally slidable relative to the second elongate element to lock engagement of the second distal end portion with the second implant.
In at least one embodiment, the system further includes the first and second implants.
In at least one embodiment, the system further includes: a first linking member configured to engage the transverse member with the first proximal end portion of the first elongate element; and a second linking member configured to engage the transverse member with the second proximal end portion of the second elongate element; wherein the first linking member is releasably engageable with the first proximal end portion of the first elongate element and the second linking member is releasably engageable with the second proximal end portion of the second elongate element.
In at least one embodiment, the first linking member is attachable to and detachable from the first elongate element without the use of tools, and the second linking member is attachable to and detachable from the second elongate element without the use of tools.
In at least one embodiment, the first linking member comprises a first releasable engagement member movable between an engaged position and a disengaged position and vice versa, and when the first linking member is mounted on the first elongate element and the first releasable engagement member is in the engaged position, the first releasable engagement member engages a first mating engagement element of the first elongate element, thereby preventing dismounting of the first linking member from the first elongate element; and the second linking member comprises a second releasable engagement member movable between an engaged position and a disengaged position and vice versa, and when the second linking member is mounted on the second elongate element and the second releasable engagement member is in the engaged position, the second releasable engagement member engages a second mating engagement element of the second elongate element, thereby preventing dismounting of the second linking member from the second elongate element.
In at least one embodiment, the first and second releasable engagement members are respectively prebiased to the engaged position.
In at least one embodiment, the first linking member comprises a first distal end portion having a first longitudinal axis aligned with a longitudinal axis of the first elongate member when the first linking member is engaged with the first elongate member, and a first proximal end portion configured to engage with the transverse member, the proximal end portion of the first linking member having a second longitudinal axis offset from the first longitudinal axis; and the second linking member comprises a second distal end portion having a third longitudinal axis aligned with a longitudinal axis of the second elongate member when the second linking member is engaged with the second elongate member, and a second proximal end portion configured to engage with the transverse member, the second proximal end portion of the second linking member having a fourth longitudinal axis offset from the third longitudinal axis.
In at least one embodiment, the system further includes: a first ball joint interconnecting the first proximal end portion of the first linking member with the first distal end portion of the first linking member; and a second ball joint interconnecting the second proximal end portion of the second linking member with the second distal end portion of the second linking member.
In at least one embodiment, the first linking member comprises a first distal end portion, a first proximal end portion and a first ball joint interconnecting the first distal end portion and the first proximal end portion, wherein the first proximal end portion is configured to releasably engage with the transverse member and the first distal end portion is configured to releasably engage with the first elongate element; and the second linking member comprises a second distal end portion, a second proximal end portion and a second ball joint interconnecting the second distal end portion and the second proximal end portion, wherein the second proximal end portion is configured to releasably engage with the transverse member and the second distal end portion is configured to releasably engage with the second elongate element.
In at least one embodiment, the system further includes: a third elongate derotator member comprising a third elongate element having a third proximal end portion and a third distal end portion, the third distal end portion being releasably engageable with a third implant implanted in a second one of the vertebrae; a fourth elongate derotator member comprising a fourth elongate element having a fourth proximal end portion and a fourth distal end portion, the fourth distal end portion being releasably engageable with a fourth implant implanted in the second one of the vertebrae; and a second transverse member engageable with the third and fourth proximal end portions of the third and fourth elongate elements.
In at least one embodiment, the system further includes an interlevel linking assembly extending between and engaged with the first elongate derotator member and the third elongate derotator member.
In another aspect of the present invention, a system for correcting alignment of one or more vertebrae of a spine includes: a first elongate derotator member comprising a first elongate element having a first central longitudinal axis, a first proximal end portion and a first distal end portion, the first distal end portion being releasably engageable with a first implant implanted in one of the vertebrae; a first linking member comprising a first proximal end portion and a first distal end portion; a second elongate derotator member comprising a second elongate element having a second central longitudinal axis, a second proximal end portion and a second distal end portion, the second distal end portion being releasably engageable with a second implant implanted in the one of the vertebrae; a second linking member comprising a second proximal end portion and a second distal end portion; and a transverse member engageable with the first and second linking members; wherein the first distal end portion of the first linking member is configured to engage the first proximal end portion of the first elongate derotator member, the first proximal end portion of the first linking member is configured to releasably engage with the transverse member, and the first proximal end portion of the first linking member is articulatable in three dimensions relative to the first distal end portion of the first linking member when the first distal end portion of the first linking member is fixed relative to the first elongate derotator member; and wherein the second distal end portion of the second linking member is configured to engage the second proximal end portion of the second elongate derotator member, the second proximal end portion of the second linking member is configured to releasably engage with the transverse member, and the second proximal end portion of the second linking member is articulatable in three dimensions relative to the second distal end portion of the second linking member when the second distal end portion of the second linking member is fixed relative to the second elongate derotator member.
In at least one embodiment, the first proximal end portion of the first linking member further comprises a first driver actuatable to releasably lock the transverse member in engagement with the first linking member and to releasably lock the first proximal end portion of the first linking member relative to the first distal end portion of the first linking member, thereby preventing articulation of the first proximal end portion of the first linking member relative to the first distal end portion of the first linking member; and the second proximal end portion of the second linking member further comprises a second driver actuatable to releasably lock the transverse member in engagement with the second linking member and to releasably lock the second proximal end portion of the second linking member relative to the second distal end portion of the second linking member, thereby preventing articulation of the second proximal end portion of the second linking member relative to the second distal end portion of the second linking member.
In another aspect of the present invention, a derotator member useful in a system for correcting alignment of one or more vertebrae of a spine includes: a first elongate element having a first proximal end portion and a first distal end portion, the first distal end portion being longitudinally split into at least two split portions configured to releasably engage with an implant implanted in one of the vertebrae; and a second elongate element slidable over the first elongate element, the second elongate element having a second proximal end portion and a second distal end portion; wherein the second distal end portion is slidable over at least part of the split portions thereby preventing the split portions from deforming away from one another; and wherein the distal end portion is slidable away from the split portions to an extent to allow the split portions to deform away from one another.
In at least one embodiment, the distal end portion is hollow, the derotator member further comprising protrusions extending inwardly from the split portions, the protrusions configured to be inserted into female mating features on a head of the implant to engage the implant.
In at least one embodiment, the first elongate element comprises two split portions and each the split portion comprises two protrusions.
In at least one embodiment, the first elongate element is hollow, allowing a tool to be inserted through a proximal opening thereof in the proximal end portion to engage a portion of the implant when the distal end portion is engaged with the implant.
In at least one embodiment, the derotator member further includes a keyed outer surface at the proximal end portion of the first elongate member, the keyed outer surface configured to engage with a mating keyed inner surface of a linking member to prevent rotation of the linking member relative to the first elongate member.
In at least one embodiment, the derotator member further includes a recess in an outer surface of the proximal end portion of the first elongate member, the recess configured to engage with a locking feature of a linking member to prevent detachment of the linking member from the first elongate member when the locking feature is engaged in the recess.
In at least one embodiment, the keyed outer surface allows multiple angular orientations of the linking member relative to a transverse axis of the first elongate member.
In at least one embodiment, the derotator member is provided in combination with a linking member engaged with the first elongate member.
In another aspect of the present invention, a linking member for linking a derotator member to a transverse member in a system useful for correcting alignment of one or more vertebrae of a spine includes: a distal end portion and a proximal end portion; the distal end portion comprising a first opening configured to receive and releasably engage with a proximal end portion of the derotator member; the proximal end portion comprising a second opening configured to receive and releasably engage with the transverse member, wherein the second opening is oriented transverse to an orientation of the first opening; a surface defining the first opening comprising a keyed inner surface configured to maintain an angular orientation of the linking member relative to a transverse axis of the derotator member when the linking member is engaged with the derotator member; a locking element movable from a locked configuration to an unlocked configuration and vice versa, wherein, when in the locked configuration, the locking element extends into the first opening; and wherein the proximal end portion is articulatable relative to the distal end portion in three dimensions.
In at least one embodiment, the linking member further includes an unlocking actuator actuatable to move the locking element from the locked configuration to the unlocked configuration.
In at least one embodiment, the locking element is biased to the locked configuration, so that when the actuator is not being actuated, the locking element is in the locked configuration.
In at least one embodiment, the keyed inner surface is multifaceted and permits selection from multiple different angular orientations of the linking member relative to the transverse axis of the derotator member, wherein the linking member is maintained in a selected angular orientation once engaged with the derotator member at the selected angular orientation.
In at least one embodiment, the linking member further includes a driver actuatable to releasably lock the transverse member in engagement with the linking member after insertion of the transverse member into the second opening, and to releasably lock the first end portion of the linking member relative to the distal end portion of the linking member, thereby preventing articulation of the proximal end portion relative to the distal end portion.
In at least one embodiment, the linking member is provided in combination with a handle having first and second ends, wherein the second end of the handle is configured to mate with the driver and, upon mating with the driver, the handle is manipulatable to operate the driver.
In at least one embodiment, the linking member further includes protrusions extending into the second opening, the protrusion configured to increase friction with the transverse member upon receipt and engagement of the transverse member by the proximal end portion.
In at least one embodiment, the linking member further includes a ball joint interlinking the proximal end portion and the distal end portion and facilitating articulation of the proximal end portion relative to the distal end portion.
In at least one embodiment, the linking member is provided in combination with a transverse member and a derotator member, wherein the distal end portion of the linking member is engaged with and fixed relative to the derotator member and the transverse member is received in the proximal end portion, while the proximal end portion and the transverse member are free to articulate in three dimensions relative to the distal end portion.
In at least one embodiment, the linking member is provided in combination with a transverse member and a derotator member, wherein the distal end portion of the linking member is engaged with and fixed relative to the derotator member and the proximal end portion is fixed relative to the transverse member, wherein the transverse member is and the proximal end portion are fixed relative to the distal end portion.
In at least one embodiment, the linking member is provided in combination with a handle having first and second ends, wherein the second end of the handle is configured to mate with a driver configured to drive locking of the transverse member and the proximal end portion relative to the distal end portion and, upon mating with the driver, the handle is manipulatable to operate the driver; and wherein the first end of the handle is configured to be inserted into a proximal opening of the derotator member and, upon insertion into the proximal opening, the handle is manipulatable to drive movement of the derotator member and transverse member.
In another aspect of the present invention, an interlevel linking assembly for linking at least two derotator members on one side of a spine in a system useful for correcting alignment of one or more vertebrae of the spine includes: an elongate interlink member having a length sufficient to span the locations of all of the derotator members to be linked; and a plurality of interlink clamps configured to securely engage the derotator members, each the interlink clamp comprising: clamp jaws configured to releasably engage the derotator member; a shaft extending from the clamp jaws; and a driver actuatable on an end of the shaft extending away from the clamp jaws to actuate the clamp jaws to clamp down on the derotator member; wherein the shaft has sufficient length to extend through an opening in the elongate interlink member and engage the driver on one side of the elongate interlink member while the clamp jaws are positioned on an opposite side of the elongate interlink member.
In at least one embodiment, the interlink clamps are configured to snap fit onto the respective derotator members, after which further clamping force is applicable by actuation of the drivers.
In at least one embodiment, the interlevel linking assembly further includes a base adjacent the clamp jaws, wherein the driver cooperates with the base to drive clamping action of the clamp jaws.
In at least one embodiment, the base is selectable from a plurality of bases each having a different length, and wherein different length bases are selectable to compensate for varying distances between the elongate interlink member and the derotator members.
In at least one embodiment, the elongate interlink member comprises a unitary plate.
In at least one embodiment, the unitary plate comprises a slot extending longitudinally therein, the slot having a length sufficient to span the locations of all of the derotator members to be linked.
In at least one embodiment, the interlink clamps are slidable in the slot, prior to fixation of the interlink clamps.
In at least one embodiment, the interlink clamps are rotatable in the slot, within a controlled range of rotation, prior to fixation of the interlink clamps.
In at least one embodiment, the elongate interlink member comprises a plurality of linked plates, the linked plates being axially rotatable relative to one another, within a controlled range of rotation.
In at least one embodiment, at least one of the linked plates comprises a slot extending longitudinally therein, and wherein one of the interlink clamps is slidable in each slot, prior to fixation thereof.
In at least one embodiment, the interlevel linking assembly is fixedly clamped to the plurality of derotator members.
In at least one embodiment, the interlevel linking assembly is provided in combination with a second plurality of the derotator members on an opposite side of the spine, interconnected to the plurality of derotator members by respective transverse members.
In another aspect of the present invention, a system for correcting alignment of one or more vertebrae of a spine includes: a plurality of pairs of elongate derotator members, each the member comprising a elongate element having a longitudinal axis, a proximal end portion and a distal end portion, the distal end portion being releasably engageable with an implant implanted in one of the vertebrae in a manner that the longitudinal axis is substantially aligned with a longitudinal axis of the implant; wherein a first of each the pair is located on a first side of the spine and engageable with an implant implanted on a first side of the vertebra and a second of each pair is respectively located on a second side of the spine and engageable with an implant on the same vertebra on the second side of the spine, and wherein each the derotator member on the first side of the spine is adapted to be engaged to a different vertebra from the vertebra that each of the other derotator members on the first side of the spine is adapted to be engaged to; a plurality of interlink members with one of the interlink members attached to each of the derotator members, respectively; a plurality of transverse members with one of the transverse members attached to each the pair of derotator members through the interlink members, respectively, wherein the transverse members connect to the interlink members at locations offset from the longitudinal axes of the elongate elements; and at least one handle attached to one of a proximal opening of one of the elongate elements or a proximal end portion of one of the interlink members.
In at least one embodiment, the system further includes an interlevel linking assembly attached directly to a plurality of the derotator members on one of the first and second sides of the spine.
In another aspect of the present invention, a method of assembling a system for correcting alignment of a spinal column of a patient includes: engaging a distal end portion of respective first and second derotation members to respective ones of first and second implants implanted in a vertebra of the spinal column on opposite sides of the spinal column; engaging a first interlink member with a proximal end portion of the first derotation member and engaging a second interlink member with a proximal end portion of the second derotation member; engaging a transverse member with proximal end portions of the first and second interlink members, at locations offset from longitudinal axes of the first and second derotation members, respectively; and manipulating at least one member of the system to align the spinal column.
In at least one embodiment, the method further includes engaging at least one handle with at least one location selected from a proximal end portion of one of the derotation members and a proximal end portion of one of the interlink members, such that the handle is substantially aligned with the longitudinal axis of the respective derotation member or proximal end portion of the interlink member; and wherein the manipulating at least one member includes manipulating the at least one handle.
In at least one embodiment, the method further includes implanting the first and second implants prior to the engaging a distal end portion of respective first and second derotation members to respective ones of first and second implants implanted in a vertebra of the spinal column on opposite sides of the spinal column.
In at least one embodiment, the method further includes engaging first and second elongate stabilization elements to the first and second implants, respectively, after the manipulating to provide post-operative stabilization.
In at least one embodiment, the method further includes: engaging a distal end portion of respective third and fourth derotation members to respective ones of third and fourth implants implanted in a second vertebra of the spinal column on opposite sides of the spinal column; engaging a third interlink member with a proximal end portion of the third derotation member and engaging a fourth interlink member with a proximal end portion of the fourth derotation member; and engaging a second transverse member with proximal end portions of the third and fourth interlink members, at locations offset from longitudinal axes of the third and fourth derotation members, respectively.
In at least one embodiment, the method further includes engaging an interlevel linking assembly to adjacent ones of the derotation members on one side of the spinal column.
In at least one embodiment, the method further includes inserting a tool through a longitudinally extending opening in one of the derotator members and performing an operation on the implant that the one of the derotator members is engaged with, from a location proximal of a proximal end the one of the derotator members.
In at least one embodiment, the operation causes a head of the implant to establish a selectable degree of cold welding with a stabilization member received by the implant.
In at least one embodiment, the operation causes a selectable degree of cold welding between a head and a shaft of the implant.
In at least one embodiment the selectable amount of cold welding by the implant with the stabilization member and the selectable amount of cold welding between the head and the shaft of the implant occur during the same operation.
In at least one embodiment, the operation fixes a stabilization member received by the implant, relative to the implant. the engagement of the distal portion comprises pressing the derotator member against the implant to deform a distal opening of the derotator member outwardly and snap fitting the distal portion to the implant.
In at least one embodiment, the method further includes sliding a sleeve distally over the distal portion after the snap fitting to prevent outward deformation of the distal opening.
In at least one embodiment, the engagement of the distal portion comprises engaging inwardly extending protrusions at the distal portion in recesses in the implant.
In at least one embodiment, the method further includes sliding a sleeve distally over the distal portion after engaging the protrusions in the recesses to prevent escape of the protrusions from the recesses.
In at least one embodiment, the proximal end portions of the interlink members are three-dimensionally adjustable relative to the respective derotator members that the interlink members are engaged to, the method comprising three-dimensionally adjusting at least one of the proximal end portions to align with the transverse member for engagement therewith.
In at least one embodiment, the method further includes locking the proximal end portions relative to the respective derotator members, after engaging the transverse member, to prevent articulation of the proximal end portion and the transverse member relative to the derotator member.
In at least one embodiment, the method further includes axially rotating a portion of the interlevel linking assembly relative to another portion of the interlevel linking assembly to better conform to variances in orientations of the derotator members.
These and other features of the present invention will become apparent upon reading the detailed description of the systems, assemblies, components and methods below.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 shows a pair of elongate derotator members linked or engaged with a transverse member by use of linking members according to an embodiment of the present invention.
FIG. 2A is an isolated, plan view of one of the derotator members shown inFIG. 1.
FIG. 2B is an isolated view of an inner elongate element of the derotator member ofFIG. 2A.
FIG. 2C is an isolated view of an outer element that is slidably receivable over the element shown IFIG. 2B.
FIG. 2D is a view of the derotator member ofFIG. 2A in an unlocked configuration.
FIG. 2E is a detailed view of the portion ofFIG. 2D indicated withincircle2E.
FIG. 3A is an isolated, perspective view of a linking member, according to an embodiment of the present invention.
FIG. 3B shows the linking member ofFIG. 3A engaged with the derotator member ofFIG. 2A.
FIG. 3C is a cross sectional view ofFIG. 3A taken alongline3C-3C.
FIG. 3D is a partial longitudinal sectional view of the linking member ofFIG. 3A.
FIG. 4 is a longitudinal sectional view of an implant according to an embodiment of the present invention.
FIG. 5 is a partial view showing locking of a derotator member to an implant according to an embodiment of the present invention.
FIG. 6A is a perspective view of an interlevel linking assembly according to an embodiment of the present invention.
FIG. 6B is a perspective view of the elongate interlink member ofFIG. 6A.
FIG. 6C is a perspective view of an elongate link member according to another embodiment of the present invention.
FIG. 6D is a longitudinal sectional view of the elongate link member ofFIG. 6C.
FIG. 6E is an exploded view of a clamp shown inFIG. 6A.
FIG. 6F is a longitudinal sectional view of a clamp shown inFIG. 6A.
FIG. 6G illustrates clamps of varying lengths according to an embodiment of the present invention.
FIG. 6H is a perspective view of a clamp loosely engaged in an (partial view of) an elongate link member according to an embodiment of the present invention.
FIG. 6I is a cross-sectional view ofFIG. 6H taken along line6I-61.
FIG. 7 is a plan view of a handle according to an embodiment of the present invention.
FIG. 8A illustrates a system comprising a plurality of the assemblies shown inFIG. 1, according to an embodiment of the invention.
FIG. 8B illustrates the system ofFIG. 8A interlinked by an interlevel linking assembly according to an embodiment of the present invention.
FIGS. 9A-9C illustrate systems having various handle installation arrangements, according to various embodiments of the present invention.
FIGS. 10A-10I illustrate a method of assembling the assembly ofFIG. 1 to establish derotator triangulation, according to an embodiment of the present invention.
FIG. 11 illustrates insertion of a tool through a proximal end opening of a derotator member to access and implant and perform an operation thereon, according to an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTIONBefore the present instruments, assemblies and methods are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a member” includes a plurality of such members and reference to “the handle” includes reference to one or more handles and equivalents thereof known to those skilled in the art, and so forth.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
Spinal derotation instrumentation is provided to carry out one or more derotation maneuvers on one or more vertebrae of a patient's spine to correct or improve the orientation of the one or more vertebrae to more closely achieve the normal curvature of the spine. For each of at least one vertebra, a pair of derotation posts are respectively attached to a pair of spinal implants implanted in the vertebra on opposite sides of the vertebra. For each pair of derotation posts connected, a linking member is installed to connect the pair. One or more handles installed on and extending from the derotation posts can then be grasped and used to apply torque to the posts to reposition the vertebra. Posts connected to multiple vertebrae can be linked together and rotated in unison. Alternatively, vertebrae can be independently rotated. Still further, groups of posts on multiple vertebrae can be linked, with still one or more vertebrae having posts attached thereto remaining independent for independent rotation thereof.
Referring now toFIG. 1, a pair of elongatederotator members10 are shown linked or engaged with atransverse member40 by use of linkingmembers30 according to an embodiment of the present invention.FIG. 2A is an isolated, plan view of one of thederotator members10 shown inFIG. 1.Derotator member10 includes an innerelongate element12, as shown in isolation inFIG. 2B. Innerelongated element12 is typically formed as a rigid tube withsplit portions14 being formed at a distal end thereof and forming the distal end portion of theelement12. Necked or otherwise narrowedportions14N interconnect thesplit portions14 with theintegral tubular portion13 ofelement12. This provides splitportions14 with resilient flexibility so that they can deform away from one another and then spring back to the restating configuration shown inFIG. 2B, as will be described in greater detail below.Protrusions14P extend inwardly from distal end portions ofsplit portions14.Protrusions14P (see the detail view ofFIG. 2E) are configured to be inserted into female mating features on a head of an implant to engage the implant, as described in more detail below. Although two splitportions14 as shown are preferred, the invention is not so limited, as two, three or even more split portions could be provided to function in a same or similar manner. Likewise, it is preferred that fourprotrusions14P, two on each split portion are provided, although more or fewer could be used.
Element12 is hollow along its interior length and includes aproximal end opening16P that permits a tool to be inserted through theelement12 from opening16P to extend to the distal end portion of the element and perform an operation on an implant (such as a pedicle screw or other implant) engaged by thesplit portions14. The proximal end portion ofelement12 includes a keyedouter surface16K configured to engage and mate with a mating keyedinner surface30M (seeFIG. 3A) of linkingmember30 to prevent rotation of the linkingmember30 relative to theelongate member12/derotator member10. As shown, keyedsurface16K is a multifaceted, polygonal configuration, although other polygonal as well as other multifaceted configurations could be substituted. It is preferred that thekeyed surface16K andmating surface30M are configured so that linkingmember30 as be engaged withelongate member12 in more than one orientation, where the different orientations are achieved by rotating the linking member about the longitudinal axis L-L relative to the elongate member. Thus, the keyed outer surface allows multiple angular orientations of linkingmember30 relative to a transverse axis T-T of theelongate member12/derotator member10. In each different selectable orientational position, the linkingmember mating surface30M mates withkey surface16K when linkingmember30 is mounted on the proximal end portion ofelement12 and thereafter prevents rotation of the linkingmember30 relative toelement12 about axis L-L. A recessedlocking feature16R such as a recess, groove or other equivalent structure is provided to cooperate with a locking feature of linkingmember30 to prevent the linkingmember30 from moving axially relative toelement12 along axis L-L after engagement of the linking member with theelement12, and thus preventing inadvertent detachment of the linking member fromelongate member12 when the locking feature of the linkingmember30 is engaged in recessedlocking feature16R.
FIG. 2C is an isolated view of anouter element18 that is slidably received overelement12 ofderotator member10.Element18 is preferably a rigid tube having a length less than the length ofelement12 so that it can be slid between an engaged or locked position (illustrated inFIG. 2A) and a disengaged or unlocked position (illustrated inFIG. 2D). In the disengaged position shown inFIG. 2D, all or a major portion of thesplit portions14 extend distal of the distal end ofelement18. This allows splitportions14 to deform away from one another as the distal end ofelement12/portions14 contact the proximal end of animplant200 to be engaged, as illustrated inFIG. 2D The distal end(s) ofelement12/portions14 may be beveled inwardly to facilitate driving the portions away from each other as they are driven against the distal end edge surfaces of theimplant200. As thederotator member10 is driven further distally relative to theimplant200, theprotrusions14P pass over the external surface of a distal portion of theimplant200 until they reach the level of female mating features202 (see Fig. **) of theimplant200. Theportions14 resiliently move toward one another (driven by the spring force developed during the deformation away from one another) thereby engagingprotrusions14P in mating features202. At this stage, element/sleeve18 is next slid distally relative toelement12, from a position such as illustrated inFIG. 2A to a position shown inFIG. 2D, where the distal end portion ofelement18 surrounds substantially all of thesplit portions14, thereby preventing the ability ofsplit portions14 to deform away from one another, and ensuring thatprotrusions14P remain engaged in mating features202, thereby lockingderotator member10 to implant200. Alternatively, splitportions14 can be configured such that, in their unbiased positions, they extend slightly apart from one another, such that thesplit portions14 andprotrusions14P can pass over the distal end portion of the implant without deforming. In this case, aselement18 is slid from the unlocked position to the locked position, it compresses the split portions, driving them toward one another and driving theprotrusions14P into the mating recesses202.
Bothelement12 andelement18 have slots or recesses (14S,18S respectively) that are configured to allow a stabilization element (such as a rod, bar, plate or the like) received byimplant200 to also extend through theelements12,18 ofderotator member10.Element12 includes aslot14L that is engaged by apin18P that extends inwardly intoelement18.Slot14L functions as a track along whichpin18P slides, thereby ensuring thatrecesses14S,18S align in the locked position, and also preventselement18 from sliding off ofelement12 if the assembly is inverted prior to attaching linkingmember30 toelement12. In at least one embodiment,slot14L is a Z-shaped or L-shaped slot formed inelement12 that is engaged bypin18P.
Turning now toFIG. 3A, an isolated, perspective view of linkingmember30 is shown, according to an embodiment of the present invention.FIG. 3B illustrates the linking member20 ofFIG. 3A engaged with thederotator member10 shown inFIG. 2A. Linkingmember30 includes aproximal end portion30P and adistal end portion30D.Distal end portion30D includes anopening32 configured and dimensioned to receive a proximal end portion ofelement12 as described above. The mating keyedinner surface30M prevent rotations of the linkingmember30 relative to theelongate member12/derotator member10 once engaged therewith as shown inFIG. 3B. Prior to that, the keying configuration shown allows selection from a plurality of different rotational orientations of the linking member relative toelement12 as already described above.
A lockingelement34 is movable from a locked configuration (illustrated in the cross-sectional view ofFIG. 3C) to an unlocked configuration, and vice versa. In the embodiment shown, a portion of the locking element extends out from the external surface of thedistal end portion30D surrounding it, and can be pressed inwardly to move from the locked configuration to the unlocked configuration InFIG. 3C, it is shown that lockingelement34 is biased to the locked configuration by biasingmember34B. When linkingmember30 is mounted over the proximal end portion ofelement12, theactuation surface34A of lockingelement34 can be pressed inwardly so as to move the locking element34 (move to the left inFIG. 3C) to align its opening with theopening32. However, pressing theactuation surface34A inwardly during mounting is not necessary, as the lockingelement34 will self-align with the opening during mounting. However, once locked intorecess16R, it is necessary to press34A to unlock the lockingelement34. Thus, if pressed during mounting, theactuation surface34A can then be released and, as the lockingelement34 is moved distally past the distal most portion of keyedsurface16K and comes into alignment withrecess16R, biasingelement34B drives a portion of the lockingelement34 intorecess16R, thereby snapping it into place and axially locking linkingmember30 relative toelement12. This same process occurs automatically if thesurface34A is not pressed and released during mounting. Linkingmember30 can be removed fromelement12 by again depressing theactuation surface34A to unlock the lockingelement34 and linking member can be readily slid off the end ofelement12.
Proximal end portion30P includes anopening36 configured and dimension to receive and engagetransverse member40. Spikes, protrusions, knurling orother surface roughness36K can be provided on the innersurface defining opening36 so as to enhance friction between the inner surface and thetransverse member40 upon engagement therewith.Proximal end portion30P is articulatable relative to the distal end portion in three dimensions, when in an unlocked configuration. In the embodiment ofFIGS. 3A-3D,proximal end portion30P is connected todistal end portion30D by a ball and socketjoint arrangement38, seeFIG. 3D. This arrangement, in the unlocked configuration, allows rotation of proximal end portion by 360 degrees about the longitudinal axis L′-L′ of linkingmember30 and allows tilting up to amaximum angle37 of about 40 degrees, typically the maximum angle is about 20 degrees, and in at least one embodiment, the maximum angle may be about 15 degrees. This angulation, from zero degrees up to themaximum angle37 can be performed at any rotational position 360 degrees about the axis L′-L′. Thus, in an unlocked configuration,proximal end portion30P is three-dimensionally articulatable relative todistal end portion30D.
Proximal end portion30P further includes adriver39 that is actuatable to releasably lock thetransverse member40 in engagement with linkingmember30 after insertion of thetransverse member40 intoopening36. As shown in the embodiment ofFIG. 3D,driver39 includes a threadedshaft39T that can be torqued intoopening36 to apply force againsttransverse member40 when it is received therein, thereby locking the position oftransverse member40 relative toproximal end portion30P. At the same time, actuation of thedriver39 as described locks theproximal end portion30P relative to thedistal end portion30D, as the ball and socket joint is also locked andproximal end portion30P can no longer articulate relative to distal end portion39D. Thus,transverse member40,proximal end portion30P,distal end portion30D andderotator member10 are all rigidly linked at this stage. Additionally, all of these rigidly linked components are also rigidly linked toimplant200. Therefore, any movement of anycomponent40,30P,30D,10,200 will cause movement of the vertebra in which theimplant200 is implanted.
FIG. 4 is a longitudinal sectional view of animplant200 that can be used according to an embodiment of the present invention. In this embodiment,implant200 is a pedicle screw, which can be a polyaxial, monoaxial or fixed screw. In the case of a polyaxial screw, thehead204 of the implant can angulate relative to the longitudinal axis L″-L″ of the implant in the direction/plane of any transverse axis. A monoaxial screw allows thehead204 to angulate relative to L″-L″ in only one transverse plane and a fixed screw does not allow angulation of thehead204 relative to theshaft206. It is noted that this is exemplary only and that the present invention is not limited to any particular type ofimplant200 used, or even to use of a pedicle screw, as other types of implants could be used as long as they have the capability of attaching to a vertebra with sufficient attachment force to move and manipulate the vertebra, such as by rotation, without loosening or any other failure, and so long as they are configured to be engaged with and locked toelement12.
FIG. 5 is a partial view illustratingderotator member10 engaged withimplant200. A portion ofset screw208 is visible as partially extending into theopening210 formed in thehead204 ofimplant200 that is provided to receive a stabilization rod or the like. As noted above, a tool can be inserted throughelement12 to drive theset crew208 so as to lock the stabilization rod relative to thehead204 and/or to loosen it for repositioning. In addition, in cases where polyaxial or monoaxial screws are used, the tool can also be inserted to drive setscrew208 to lock or unlock the articulation capability ofhead204 relative toshaft206.
In order to rigidly link multiple assemblies of the type shown inFIG. 1, thereby rigidly linking multiple levels/vertebra of a spine to as to manipulate in unison, an interlinking assembly can be provided to engage multiple derotator assemblies and rigidly link them.FIG. 6A is a perspective view of aninterlevel linking assembly50 according to an embodiment of the present invention.Interlevel linking assembly50 includes anelongate interlink member52 having a length sufficient to span the locations of all of thederotator members10 to be linked and having sufficient rigidity to transfers forces from one derotator member to allderotator members10 connected thereto, without any significant deformation or loss of force. In the embodiment shown inFIG. 6A, theassembly50 is provided to link fourderotator members10. However, the present invention is not limited to this number, as the concepts described here are readily adaptable to assemblies configured to link two, three, or more than foundderotator members10. A plurality of interlink clamps54 are provided in theassembly50 and are configured to securely engage thederotator members10.
Interlink clamp54 includesclamp jaws56 configured to releasably engage thederotator member10; ashaft589 seeFIG. 6E) extending from theclamp jaws56; and adriver60 threadably actuatable on an end ofshaft58 extending away from theclamp jaws56 to actuate the clamp jaws to clamp down on theelement12 ofderotator member10. Theshaft58 has sufficient length to extend through anopening52L in theelongate interlink member52 and engage thedriver60 on one side ofelongate interlink member52 whileclamp jaws56 are positioned on an opposite side ofelongate interlink member52, as illustrated inFIG. 6A. In this regard,shaft58 can be threaded58T, for example anddriver knob60 can be provided with mating threads so thatdriver knob60 can be torqued against theinterlink member52. As theshaft58 is drawn into thedriver knob60 by torquing the knob60 (withclamp jaws56 being prevented from rotating about the axis ofshaft58, as having been engaged with element12) this drives thebase portion62 of the driver assembly (since it is slidable relative to shaft58) againstclamp jaws56. The concave curvature of the base surface contacting theclamp jaws56 drives the clamp jaws into compression, causing them to securely and rigidly engage theelement12 ofderotator member10. At the same time, theclamp54 becomes rigidly fixed relative to interlinkmember52. Prior to actuating thedriver60, clamp54 can slide along opening52L (typically formed as a longitudinally extending slot) and can rotate relative to the longitudinal axis ofshaft58 over a controlled range of rotation. For example, the controlled range of rotation may have a maximum angle of rotation of up to about ±170 degrees, or a maximum angle of rotation as low as about ±10 degrees. Currently, the preferred maximum angle of controlled rotation is about ±20 degrees, where theangle41 is measured between the longitudinal axis of theelongate interlink member52 and the longitudinal axis of thebase62. Thus, the clamp is rotatable in either direction from anangle41 of zero degrees up to and including the maximum angle of the controlled rotation range.Stops62S are provided on thebase member62 which contact theinterlink member52 when themaximum angle41 has been reached. Prior to actuating the driver, the clamp jaws are preferably configured and dimension to form a snap fit overelement12, so that they can be easily initially attached without the need for actuating the clamps.
InFIGS. 6A-6B, theelongate interlink member52 comprises a rigid, unitary plate and both the plate and theslot52L have a length sufficient to span all of thederotator members10 to be linked. In another embodiment, as shown inFIGS. 6C-6D,elongate interlink member52 comprises a plurality of linkedplates52′. Linkedplates52′ are axially rotatable relative to one another, within a controlled range of rotation.Pins64 are provided to interconnect theplates52′ andplates52′ are rotatable about pins64.Stops66 are provided to limit the amount of rotation of oneplate52′ relative to anadjacent plate52′ The amount of rotation may be up to about ±30 degrees, typically up to about ±15 degrees. The rotation allowed betweenlinks52′ provides an additional degree of freedom that can be useful to facilitate engagement of theassembly50 withderotator members10 having varying orientations, as it is often the case that the members will not be parallel due to the misalignment of the vertebrae that they are attached to. Additionally, clamps54 can slide and rotate about a controlled range of rotation while installed in thelinks52′, prior to final clamping through actuating thedriver60.
To still further facilitate the attachment ofassembly50 to multiplederotator members10, clamps54 of varying lengths may be provided. This can address issues where derotatormembers10 are located in orientations resulting in different distances from the plane of theinterlink member52 during attachment.FIG. 6G illustrates three different lengths of clamps54 (i.e.,54A,54B and54C) where54C has a length greater than54B and54B has a length greater than54A. the variations in length are established by the provision ofactuator bases62 having varying length. In the embodiment ofFIG. 6G. thelength62L ofbase62C is greater than the length of base62B and the length of base62B is greater than the length of base62A. This also necessitates that theshaft58 of54C is longer than the shaft of54B and the shaft of54B is longer than the shaft of54A.FIG. 6F is a longitudinal sectional view ofclaim54.
FIG. 8A illustrates a system including four sets of assemblies of the type shown inFIG. 1, attached toimplants200 implanted in four adjacent vertebrae of a spine (four levels).FIG. 8B shows the system ofFIG. 8A after rigidly interlinking the assemblies usinginterlink assembly50 in a manner as described above. The system is shown linked by aninterlink assembly50 attached to one side of the system and this is currently the preferred practice. However, the invention is not limited to this embodiment, as theassembly50 could be attached to the opposite side, or tow assemblies50 (one on each side) could be implemented. Still further,multiple assemblies50 can be used on one side. For example, oneassembly50 could be engaged to link twoadjacent members10 and asecond assembly50 could be engaged to link twoother members10.
FIG. 7 is a plan view of ahandle70 that can be employed as part of a system according to an embodiment of the present invention.Handle70 is sufficiently rigid in bending strength to be used to apply moments of force to theassembly300 without plastically deforming.Handle70 has sufficient torsional rigidity to allow it to be used as a driver tool A first end oftool70 comprises asocket72 configured to mate with at least one ofdriver39 anddriver60. Preferably,driver39 anddriver60 are configured with the same shape and dimensions so thathandle60 can be used to engage and drive bothdriver60 anddriver39. Additionally, one or more handles can be engaged todriver39 and/ordriver60 to apply moments of force to thesystem300 to manipulate the spine. However, it is preferred to apply force through the opposite end(s) of the handle(s)70 by engaging them in the opening(s)16P as described hereafter. Theopposite end74 oftool70 is configured and dimensioned to be received in and mate withproximal opening16P ofelement12. Upon such mating, moments of force can be applied toderotator member10 throughhandle70 andelement12.Handle70 is enlarged in the central portion to form a more comfortable fit to the hand of a use and provide more mechanical advantage when rotating to drive thesocket end72. The central portion may also be knurled, scalloped or otherwise contoured76 to enhanced friction between the handle and the hand of the user.
FIG. 9A illustratessystem300 with onehandle70 attached, whereinend74 is inserted intoopening16P of one of the derotator members.FIG. 9B. illustratessystem300 with twohandles70 attached, wherein end74 of onehandle70 is inserted intoopening16P of one of the derotator members and end74 of the other handle is inserted intoopening16P of the other derotator member attached to the same level.FIG. 9C. illustratessystem300 with onehandle70 attached, whereinend72 is mated over one of thedrivers60 ofinterlink assembly50. It is noted thatFIGS. 9A-9C are only exemplary, ashandles70 can be engaged with any combination ofopenings16P,drivers30 anddrivers60.
FIGS. 10A-10I illustrate a method of assembling the assembly ofFIG. 1 to establish derotator triangulation. Assembling asystem300 can be performed by assembling multiple assemblies in the manner described here and interlinking the assemblies using one or more interlevel linking assemblies as described above. AtFIG. 10A, derotatormembers10 are advanced toward the heads of theimplants200 having been implanted invertebra2. It is noted here that although both sides are being addressed by a single description, the components do not have to be simultaneously assembled on both sides, but can instead, be assembly sequentially. AtFIG. 10B, theprotrusions14P have engaged therecesses202 after forcing the distal ends of thederotator members10 over the heads of theimplants200. InFIG. 10C, elements18 (outer sleeves) are slid distally over thesplit portions14 to lock thederotator members10 to theimplants200.FIG. 10D illustrates an optional feature in which avisual indicator18V (such as a laser-etched arrow or other readily visually identifiable indicator) is provided onelement12 and becomes visible whenelement18 has been slid distally sufficient to properly align the distal end ofelement18 with the distal end ofelement12.
InFIG. 10E the linkingmembers30 are locked to thederotator members10. As noted above, in at least one embodiment it is possible to engage the linking member in different rotational orientations relative to the derotator member. The linkingmembers30 should be oriented such that whentransverse member40 is engaged with theopenings36, thetransverse member40 does not obstruct theopenings16P. This is important as access toopenings16P must be kept open to allow insertions of tools and/or handle70.FIGS. 10F and 10G are top and side views, respectively, illustrating an assembly in which linkingmembers30 have been oriented in acceptable positions relative toderotator members10, where it is shown thatopenings16P are readily accessible. In contrast, FIGS.10F′-10G′ are top and side views, respectively, illustrating an assembly in which linkingmembers30 have been improperly oriented relative toderotator members10, so thattransverse member40 obstructs theopenings16P making it impossible to access theopenings16P with a tool or handle70.
Upon inserting the transverse member, theproximal end portions30P of linkingmembers30 can be articulated three dimensionally, such that not only can theproximal end portions30P and transverse member be tilted toward the head of the patient or the foot of the patient, but they can also be tilted left or right, or in some angular direction in between. InFIG. 10H, after thetransverse member40 has been inserted into linkingmembers30 and thetransverse member40 and liningmember30 have been articulated relative toderotator members10 if necessary, one or more handle(s) is/are used to actuate thedrivers39 to lock thetransverse member40 relative toproximal end portion30P and to lock theproximal end portion30P relative todistal end portion30D. InFIG. 10I, theopposite end74 oftool70 is inserted into opening16pofderotator member10 and force is applied throughhandle70 to cause rotation of the assembly and the vertebra as illustrated in phantom.
FIG. 11 illustrates atool400 being used to tighten aset screw208 ofimplant200 to lock the orientation of theimplant200 relative to astabilization rod500. The working end or distal end portion of thetool400 has been inserted intoopening16P and throughelement12 to interface with theset screw208 and the set screw is torqued by turninghandle402 oftool400.
While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.